Previewing the R/Pharma Roundtable Summit: Exploring Organizational Challenges in Open Source

Text: R/Pharma Roundtable Summit at posit conf 2023. Sept 18 Chicago. A cartoon outline of the Chicago skyline.

R/Pharma is hosting their in-person event at posit::conf(2023), and we cannot wait to gather Pharma champions to discuss the future of open-source adoption across the pharmaceutical industry!

On September 18, we will host an R/Pharma Roundtable Summit, designed to be an innovative in-person event that facilitates free-flowing conversations, establishes meaningful connections, and explores the transformative potential of open source in Pharma. The summit’s advisory board includes members from Amgen, Beigene, Genentech, GSK, J&J, Novartis, PCCTC, Pfizer, Roche, and Posit.

In the spirit of open-source collaboration, the board is gathering ideas for discussion topics through GitHub, allowing for input and feedback from all Roundtable participants so they can shape the final agenda together. The agenda is still being formed; find the collection of potential topics here.

Browsing through the collection, we see a key theme forming: organizational challenges as organizations go from “consumers” to “creators and managers” of open-source tools. The participants’ thought-provoking questions range from strategies for recruiting open-source developers to navigating the complexities of licensing packages and tools.

These important topics are guaranteed to result in exciting conversations about the opportunities and challenges of transitioning to open-source tools during the R/Pharma Roundtable Summit. Below are some of the key themes we’ve noticed. We can’t wait to hear Pharma leaders offer valuable insights into how organizations are embracing these opportunities!


Validating packages individually vs in a group


In the context of the pharmaceutical industry, “validation” refers to the process of confirming that a particular tool consistently produces accurate and reliable results and meets the intended requirements and specifications. There are currently various areas of “validation” that organizations are focused on, such as validating packages, validating the environment, and validating the analytical methods and results. Much focus is on the validation of packages and environments.

In regards to the validation of analytical methods and results, the CAMIS (Comparing Analysis Method Implementations in Software) group is focused on comparing statistical results from various languages and helping to document any differences and rationale.

Historically, pharmaceutical companies have carried out validation processes independently, within their own organization. This isolated approach was due to concerns about proprietary information, data security, and the complexity of the regulatory landscape in the pharmaceutical industry. Companies tended to keep their validation methods and data internal, limiting collaboration with external entities, including other pharmaceutical companies and researchers.

However, in recent years, there has been a growing recognition of the benefits of more collaborative approaches to validation. As the pharmaceutical industry faces increasing pressures to improve efficiency, reduce costs, and accelerate drug development, collaboration and the co-creation of open-source tools have gained momentum.

One such effort is the Regulatory R Package Repository by the R Validation Hub, an R Consortium Working Group promoting collaboration across organizations to support the adoption of R within a regulatory setting. Originally chaired by Andy Nicholls from GSK, it is now led by Doug Kelkhoff from Roche. In June 2018, the R Consortium awarded funding for the R Validation Hub to create an online repository for R package validation in accordance with regulatory standards. The approach to validation is risk-based based on a number of attributes for each R package – packages that are actively maintained, well supported, documented, and have a wider user base, for example, are considered to have a lower risk. Companies can then focus validation efforts on higher-risk packages while accepting community-based testing of these lower-risk packages. The {riskmetric} package has been developed to assist with this process. 

The R/Pharma Roundtable Summit begins with a 90-minute workshop on this new repository, facilitated by Doug, followed by participant-driven conversations.


Long-term commitment to open-source tools


Transitioning to open-source tools for reporting and regulatory interaction involves significant change management and commitment. Organizations must carefully consider the necessary resources, technical support, infrastructure, and talent required to successfully adopt open source as the foundation of their operations. In this transformation, a robust governance structure becomes indispensable, ensuring that all efforts remain reproducible and sustainable in the long run. Building trust is key to acceptance within organizations and partnering across companies in the non-competitive space. Sharing knowledge and communication helps build that trust. 

R/Pharma Roundtable Summit is a valuable event where organizations can come together to share knowledge and collaborate. Participants include both those who are new to open source and those who have been using it for years. It’s a great chance for newcomers to explore the benefits of open-source tools and learn from experienced users. The event builds a sense of community, promotes innovation, and supports the idea of working together for progress in the pharmaceutical industry and beyond.


Sustainable open-source collaboration


As more people contribute to grassroots, cross-industry projects like the pharmaverse, what structures and guidelines need to be in place to foster strong, sustainable collaboration? 

The PHUSE End-to-End Open-source Collaboration Guidance exemplifies a collaborative effort across various companies, sponsored by PHUSE, to provide valuable insights into open-source use and contributions. This initiative serves as a model for safeguarding technical tools and workflows for the future, and the conversations at the R/Pharma Roundtable Summit will continue and strengthen available resources to other organizations.

From licenses to review processes, participants can explore the opportunities and challenges encountered by others and collectively pave the way for fruitful open-source collaboration.


Join the conversation in Chicago


These are just sneak peeks into the organizational topics that will be part of the R/Pharma summit, and we cannot wait to see the innovative initiatives that come out of this in-person event.

To join your contemporaries in Chicago, register for posit::conf(2023) today!